Kornimate/medical-research-clean huggingface dataset:
preoperative regional nerve block for acute and chronic post-operative pain following mastectomy

Conditions: Breast Cancer; Mastectomy; Anesthesia, Local; Narcotic Use

Summary: the purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.

surgical intervention of breast cancer is vital to breast cancer treatment or prevention and patient outcomes. however, surgical therapy can lead to chronic pain that may affect quality of life for breast cancer survivors including the potential for long-term disability. chronic pain after breast cancer surgery is common, occurring in about 25-50% of patients. this chronic pain commonly affects women following a mastectomy and is referred to as post mastectomy pain syndrome (pmps). regional anesthesia utilizing single dose nerve blocks is frequently utilized in the preoperative period for many surgical procedures and decreases postoperative pain. regional anesthesia also frequently results in decreased narcotic use in the post-operative period. the use of regional fascial plane blocks or pectoralis (pecs) blocks has increased in the setting of mastectomy. the regional block utilizes ultrasound guidance to inject local anesthesia into the fascial planes of muscles thereby infiltrate the surrounding nerves. one example is the pectoral i block which deposits local anesthetic between the pectoralis major and minor muscles and pectoral ii above the serratus anterior muscle with an intended blockade for intercostals iii, iv, v, vi and long thoracic nerves. these techniques have shown a decrease in postoperative pain and postoperative narcotic consumption. the investigators seek to evaluate if preoperative regional nerve blocks decrease post mastectomy chronic pain, improving the quality of life of breast cancer survivors. therefore, the aim of this study is to determine whether regional nerve blocks affect chronic post-mastectomy pain and whether the regional block is associated with perioperative pain and postoperative narcotic consumption.

Eligibility criteria:
inclusion criteria: 1. women at least 19 years old who are able to provide written and informed consent 2. women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (stage 0-iii) or breast cancer prevention 3. patients with asa class of i-iii will be included exclusion criteria: 1. stage iv breast cancer, morbid obesity with bmi \>45kg/m2 2. renal insufficiency (creatinine \>1.5 mg/dl) 3. current chronic analgesic use (daily use for \> or equal to 4 weeks) 4. history of opioid abuse or dependence 5. presence of chronic pain with a self-reported average pain score of 4 or greater on a pain scale of 0-10 prior to any surgical intervention 6. incarceration 7. pregnancy 8. immediate autologous tissue reconstruction.
efficacy of sr121463b in patients with syndrome of inappropriate antidiuretic hormone secretion

Conditions: Syndrome of Inappropriate ADH (SIADH) Secretion; Hyponatremia

Summary: the study is designed to assess the efficacy of an investigational drug called sr121463b (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the syndrome of inappropriate antidiuretic hormone secretion (siadh). this double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

this is a multicenter worldwide study with 32 participating men and women aimed to figure out whether sr121463b is safe and effective in correcting low levels of sodium in blood in subjects with siadh. the participation in the study lasts up to 34 days. after screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of sr121463b or a matching placebo. during the second part of the study (23 days), subjects receive either capsules of sr121463b or no treatment. the subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. women of childbearing potential must have an approved method of contraception.

Eligibility criteria:
siadh of any origin

Keywords: low blood sodium (hyponatremia) siadh inappropriate adh syndrome
study of ter-101 topical ointment in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this phase 2 study will assess efficacy, safety, and tolerability of ter-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.


Eligibility criteria:
inclusion criteria: * adolescent or adult subject aged 12 - 65 years. * overall iga score of 2 (mild) or 3 (moderate) at baseline on a 5-point iga exclusion criteria: * ad with known hypersensitivity to excipients of ter-101 ointment * subjects who are immunocompromised
effect of attentional therapy on post-traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is associated with an attentional bias towards negative stimuli, which is supposed to contribute to the development and the maintenance of the disorder. we recently showed using eye-tracking evidenced two types of ab towards negative stimuli: a "physiological ab" found both in healthy and individual with ptsd, characterized by a stronger initial attentional engagement towards negative stimuli compared to neutral stimuli, as revealed by longer first fixation duration dwell time on negative pictures than on neutral pictures; a "pathological bias" observed only in individuals with ptsd and characterized by an heightened sustained attention towards negative stimuli once detected, which further increases with prolonged exposure. the present study aimed at assessing the effectiveness of an eye-tracking assisted attentional bias reduction therapy, targeting specifically the pathological bias on the reduction of ptsd symptoms


Eligibility criteria:
inclusion criteria: * understanding and able to express themselves in french * giving informed consent, by dating and signing the study participation form * having health insurance coverage * normal or corrected to normal vision and hearing * dsm-5 ptsd criteria, assessed using the caps and pcl-5 exclusion criteria: * minors or adults under guardianship, under judicial protection, persons deprived of liberty * pregnant or breastfeeding women * refusal to participate after being clearly and fairly informed about the study * sensory, visual or auditory incapacity to participate in the study * personal history of neurological disorder or current neurological disorder * use of drugs other than tobacco and alcohol * alcohol use on the day of experimentation * personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, or trauma and stress disorders assessed at clinical interview and with mini * personal history of multiple trauma in childhood * psychotropic medication treatment not stabilized over the past 4 weeks * moca \< 26 * contraindication to prolonged exposure therapy

Keywords: post-traumatic stress disorder attentional bias eye tracking attention control training
a study of dvs sr in treatment of children and adolescent outpatients with mdd

Conditions: Major Depressive Disorder

Summary: this is a double-blind study evaluating desvenlafaxine succinate sustained-release (dvs sr) versus placebo in the treatment of children and adolescent outpatients with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * age \>=7 and \<18 years of age * primary diagnosis of major depressive disorder (mdd) * cdrs-r score \>40 exclusion criteria: * history of suicidal behavior or requires precaution against suicide * not in generally healthy medical condition * history of psychosis or bipolar disorder * seizure disorder

Keywords: major depressive disorder mdd depression
effects of the mindfulness meditation practices on cognition

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: adults with attention deficit hyperactivity disorder (adhd) have impairments in attentional subsystems of alerting and conflict monitoring. mindfulness meditation may lead to an improvement of these deficits, and reduces symptoms of anxiety and depression. however, the studies that demonstrated these improvements did not use a control group, nor controlled the use of medication. in the present study the investigators will examine the effects of the mindfulness practices (same protocol of 8 weekly sessions used in the study that showed positive effects in this disorder) in the performance of adult patients and healthy people (with adhd). cognitive performance, mood, and the quality of life will be assessed by validated questionnaires before and after treatment/standby.


Eligibility criteria:
inclusion criteria: * portuguese as their first language; * minimum of eight years of formal education; * normal vision or corrected to normal and normal hearing; * no prior experience with meditation; * patients should be taking stable doses of methylphenidate (for at least a month) for their disorder as prescribed by their doctors. exclusion criteria: * patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or tourette's syndrome.

Keywords: meditation cognition attention deficit disorder with hyperactivity
efficiency of a small-peptide enteral feeding formula compared to a whole-protein formula

Conditions: Traumatic and/or Non-traumatic Brain Injury; Critically Ill

Summary: an early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients. previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. an improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.

this open-labelled prospective randomized trial aims to compare 2 groups of patients: the study group and the control group. the randomization process will concern the allocation of the type of enteral feeding formula administered for nutritional support: peptamen® af in the study group, and sondalis® hp in the control group. 2 centers are involved in this study. each patient admitted in the critical care unit will be assessed for eligibility. after written informed consent is obtained from relatives, patient without any exclusion criteria will be included in the study. the allocation of the type of enteral nutritional feeding formula will be randomized after inclusion. enteral nutrition according to the randomization group will start within the 48 hours of admission and up to 10 days, if requested. beyond the 10th day, all patients will receive standard enteral nutrition formula. after inclusion, data regarding efficacy and tolerance will be assessed daily up to day 10. mortality and outcome will be assessed at day 28 and at day 60.

Eligibility criteria:
inclusion criteria: * admission in our surgical critical care unit. * traumatic brain injury. * non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma. * expected duration of mechanical ventilation \> 48 hours. exclusion criteria: * abdominal surgery in the previous 30 days. * pregnancy. * breast-feeding. * hemodynamic instability defined as infusion of norepinephrine \> 3 mg/h, or epinephrine \> 1 mg/h, or as increasing needs in vasopressive or inotropic drugs.
effects of levosimendan in acute kidney injury after cardiac surgery

Conditions: Acute Kidney Injury; Renal Insufficiency, Acute

Summary: acute kidney injury (aki) is a common complication after cardiac surgery. mismatch in renal oxygen demand-supply may be an important pathogenetic factor. levosimendan has been shown to improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy controls after cardiac surgery. in order to investigate the effect of levosimendan in patients with aki after cardiac surgery, the investigators plan a randomized placebo controlled trial. 30 patients will receive levosimendan or placebo. renal blood flow and filtration fraction will be measured using infusion clearance technique of para-aminohippuric acid and chromium ethylenediaminetetraacetic acid (cr-edta) respectively.


Eligibility criteria:
inclusion criteria: * patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass * acute kidney injury, defined as increase in s-creatinine 50% or 27 mol/l * normal s-creatinine before surgery exclusion criteria: * ongoing treatment with inotropic drugs (not norepinephrine) * central venous oxygen saturation (scvo2) \< 60% despite optimization of hematocrit and volume status * need of renal replacement therapy * ongoing bleeding * patient or next of kin does not consent with study participation

Keywords: acute kidney injury cardiac surgery renal blood flow levosimendan
a study of lebrikizumab (ly3650150) in participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male or female, 18 years or older. * chronic ad as defined by hanifin and rajka (1980) that has been present for ≥1 year before the screening visit . * eczema area and severity index (easi) score ≥16 at the screening and the baseline visit. * investigator global assessment (iga) score ≥3 (scale of 0 to 4) at the screening and the baseline visit. * ≥10% body surface area (bsa) of ad involvement at the screening and the baseline visit. exclusion criteria: * treatment with any of the following agents within 4 weeks prior to the baseline visit: * immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, ifn-γ, janus kinase inhibitors, azathioprine, methotrexate, etc.) * phototherapy and photochemotherapy (puva) for ad. * treatment with topical corticosteroids (tcs) or topical calcineurin inhibitors (tci) within 1 week prior to the baseline visit. * treatment with: * an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit. * dupilumab within 3 months prior to baseline visit. * cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit. * other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer). * use of prescription moisturizers within 7 days of the baseline visit.

Keywords: eczema
understanding family refusal

Conditions: Brain Death; Renal Failure

Summary: the investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation.


Eligibility criteria:
inclusion criteria: * citizens or permanent residents of singapore * above 21 exclusion criteria: - below 21

Keywords: organ donation transplantation intensive care
bioequivalence study of levetiracetam tablet and intravenous infusion in healthy japanese subjects

Conditions: Healthy Volunteers

Summary: the purpose of this study is to investigate the pharmacokinetics(pk) and evaluate the bioequivalence of levetiracetam (lev) following a single 15-minutes iv infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: * healthy japanese male and female volunteers with the age between 20 and 55 years old exclusion criteria: * subject has participated or is participating in any other clinical studies of investigational drug or another imp within the last 3 months * subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters) * subject is pregnant or lactating female.

Keywords: healthy volunteers japanese
treating non-epileptic seizures using magnetic brain stimulation

Conditions: Nonepileptic Seizures

Summary: the purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rtms) - a form of non-invasive brain stimulation - to decrease the frequency of psychogenic non-epileptic seizure (pnes) episodes in patients with pnes.

this study is an open label pilot study that aims to recruit 15 individuals with diagnosed pnes to investigate the feasibility of using repetitive transcranial magnetic stimulation (rtms) to decreasing the frequency of psychogenic non-epileptic seizure (pnes) episodes. rtms is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to active neurons in a specified target location of the brain. electronic as well as paper-and-pencil questionnaires will be used to asses patient's psychiatric symptoms and functional impairment both before and after treatment to monitor symptom-changes.treatment will consist of daily sessions of high frequency (20 hz) rtms applied over the right temporoparietal junction (tpj) of the cerebral cortex. patients will receive two sessions per day for 15 consecutive weekdays. each session will take approximately 20 minutes to complete. results of the questionnaires will be analyzed to determine the effect of the treatment on pnes episodes and functional impairment. as a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. both patient response and tolerability to rtms will be analyzed.

Eligibility criteria:
inclusion criteria: * confirmed psychogenic non-epileptic seizures exclusion criteria: * evidence of previous or comorbid epileptic seizures * major comorbid neurological diseases * currently taking medications that are known to reduce seizure-threshold * currently pregnant

Keywords: psychogenic non-epileptic seizure transcranial magnetic stimulation brain stimulation
myfortic - treatment for extensive cgvhd

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to determine whether the response to treatment for extensive chronic graft versus host disease (cgvhd)is improved with the addition of myfortic alongside cyclosporine a and prednisone, compared to the reference treatment of cyclosporine a and prednisone alone.

this clinical trial is a european, multi-center, randomized, double blinded placebo-controlled trial comparing csa+pdn+mpa versus the reference treatment of csa+pdn alone + placebo, in patients with extensive chronic gvhd. randomization will be stratified according to: * platelet number (low versus high risk) * source of transplantable cells (marrow versus pbsc versus cord blood) patients not in progression at 6 weeks post randomization (progression defined as primary failure) will be evaluated for remission (complete or partial) at 3, 6, 9, \& 12 months post randomization

Eligibility criteria:
inclusion criteria: * age 18 - 60 * any primary diagnosis requiring treatment by hematopoietic stem cell transplantation * recipient of a single allogeneic stem cell transplant (bone marrow or peripheral blood stem cells, or cord blood) minimum 80 days ago * received a graft from a related or an unrelated donor * conditioning regimen: myeloablative or non-myeloablative * patients suffering a first episode of extensive chronic gvhd, without recurrent disease * the diagnosis of chronic gvhd requires the following: * distinction from acute gvhd * presence of at least one diagnostic clinical sign of chronic gvhd or presence of at least one distinctive sign confirmed by pertinent biopsy or other relevant diagnostic tests * exclusion of other possible diagnoses * receiving a standard prophylaxis regimen for acute gvhd: csa plus methotrexate, or csa+mmf for nma, or a t-cell depleted transplant * patient gives written informed consent prior to randomization exclusion criteria: * patient age less than 18 years or over 60 years. * gvhd prophylaxis by tacrolimus plus methotrexate * delayed onset acute gvhd following nma or dli * second allogeneic stem cell transplant * not the first episode of chronic gvhd needing systemic immunosuppressive therapy. * limited chronic gvhd (seattle criteria, see appendix 1) * uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 week of randomization * in the opinion of the investigator, if the patient has significant medical or psychosocial problems or unstable disease status * pregnant or lactating females * known hypersensitivity to mycophenolic acid

Keywords: gvhd graft versus host disease extensive myfortic
effectiveness of ophthalmic antiseptic preparations

Conditions: Antiseptics; Microbiota; Conjunctiva

Summary: the aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (pvi) and chlorhexidine (chx), in reducing conjunctival bacterial flora.

70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used pvi 0.66% 4 times daily starting 3 days before surgery; 35 patients used chx 0.02% with the same posology. the contralateral eye was considered as control. conjunctival swabs were collected in both eyes at the baseline (t0) and after three days of treatment (t1) all before cataract surgery. conjunctival bacterial load has been evaluated through a molecular based method at t0 and t1 and compared to the control eye.

Eligibility criteria:
inclusion criteria: * patients undergoing cataract surgery * 18 years of age or older exclusion criteria: * reported allergy or hypersensitivity to iodine or chlorhexidine * active ocular infection * contraindication to surgery * pregnant women * patients residing in nursing homes or prison * patients who used antibiotic, antiviral or antifungal eye drops in the week preceding the intervention

Keywords: povidone-iodine chlorhexidine preoperative antiseptics conjunctival bacterial flora